[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)]
[Rules and Regulations]
[Pages 35134-35135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0440]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of 1,6-hexanediamine, 
N, N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymers with 
morpholine-2,4,6-trichloro-1,3,5-triazine reaction products, 
methylated, as a stabilizer for olefin polymers intended for use in 
contact with food. This action is in response to a petition filed by 
Cytec Industries, Inc.

DATES: The regulation is effective June 29, 1998; written objections 
and requests for a hearing by July 29, 1998.
ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 6, 1997 (62 FR 60095), FDA announced that a food 
additive petition (FAP 8B4562) had been filed by Cytec Industries, 
Inc., c/o Keller and Heckman, 1001 G St. NW., suite 500 West, 
Washington, DC 20001. The petition proposed to amend the food additive 
regulations in Sec. 178.2010 Antioxidants and/or stabilizers for 
polymers (21 CFR 178.2010) to provide for the safe use of 1,6-
hexanediamine, N, N'-bis(2,2,6,6-tetramethyl-4-piperidinyl)-, polymers 
with morpholine-2,4,6-trichloro-1,3,5-triazine reaction products, 
methylated, as a stabilizer for olefin polymers complying with 21 CFR 
177.1520 intended for use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed use 
of the additive is safe and the additive will achieve its intended 
technical effect. Therefore, the regulations in Sec. 178.2010 should be 
amended as set forth below.
    FDA's review of this petition indicates that the additive may 
contain trace amounts of formaldehyde as an impurity. The potential 
carcinogenicity of formaldehyde was reviewed by the Cancer Assessment 
Committee (the Committee) of FDA's Center for Food Safety and Applied 
Nutrition. The Committee noted that for many years, formaldehyde has 
been known to be a carcinogen by the inhalation route, but the 
Committee concluded that these inhalation studies are not appropriate 
for assessing the potential carcinogenicity of formaldehyde in food. 
The Committee's conclusion was based on the fact that the route of 
administration (inhalation) is not relevant to the safety of 
formaldehyde residues in food and the fact that tumors were observed 
only locally at the portal of entry (nasal turbinates). In addition, 
the agency has received literature reports of two drinking water 
studies on formaldehyde: (1) A preliminary report of a carcinogenicity 
study purported to be positive by Soffritti et al. (1989), conducted in 
Bologna, Italy (Ref. 1); and (2) a negative study by Til et al. (1989), 
conducted in The Netherlands (Ref. 2). The Committee reviewed both 
studies and concluded, concerning the Soffritti study, `` * * * that 
data reported were unreliable and could not be used in the assessment 
of the oral carcinogenicity of formaldehyde'' (Ref. 3). This conclusion 
is based on a lack of critical detail in the study, questionable 
histopathological conclusions, and the use of unusual nomenclature to 
describe the tumors. Based on the Committee's evaluation, the agency 
has determined that there is no basis to conclude that formaldehyde is 
a carcinogen when ingested.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.
    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for

[[Page 35135]]

FAP 8B4562 (62 FR 60095, November 6, 1997). No new information or 
comments have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before July 29, 1998, file with the Dockets Management 
Branch (address above) written objections thereto. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m and 4 p.m., Monday through Friday.
    1. Soffritti, M., C. Maltoni, F. Maffei, and R. Biaggi, 
``Formaldehyde: An Experimental Multipotential Carcinogen,'' Toxicology 
and Industrial Health, vol. 5, No. 5: 699-730, 1989.
    2. Til, H. P., R. A. Woutersen, V. J. Feron, V. H. M. Hollanders, 
H. E. Falke, and J. J. Clary, ``Two-Year Drinking Water Study of 
Formaldehyde in Rats,'' Food Chemical Toxicology, vol. 27, No. 2, pp. 
77-87, 1989.
    3. Memorandum of Conference concerning ``Formaldehyde;'' Meeting of 
the Cancer Assessment Committee, FDA, April 24, 1991, and March 4, 
1993.

List of Subjects in 21 CFR Part 178

    Food additives, Food packaging.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.
    2. Section 178.2010 is amended in the table in paragraph (b) by 
alphabetically adding a new entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

 * * * * *
    (b) * * *

------------------------------------------------------------------------
                Substances                           Limitations        
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  *                    *                    *                    *      
                   *                    *                    *          
1,6-Hexanediamine, N, N'-bis(2,2,6,6-       For use only as a stabilizer
 tetramethyl-4-piperidinyl)-, polymers       at levels not to exceed 0.3
 with morpholine-2,4,6-trichloro-1,3,5-      percent by weight of olefin
 triazine reaction products, methylated      polymers complying with    
 (CAS Reg. No. 193098-40-7).                 Sec.  177.1520(c) of this  
                                             chapter. The finished      
                                             polymers are to contact    
                                             food only under conditions 
                                             of use C, D, E, F, and G,  
                                             as described in Table 2 of 
                                             Sec.  176.170(c) of this   
                                             chapter. Provided that the 
                                             finished food-contact      
                                             articles have a volume of  
                                             at least 18.9 liters (5    
                                             gallons).                  
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: June 19, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-17144 Filed 6-26-98; 8:45 am]
BILLING CODE 4160-01-P